ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 200 units of Transpac IV transducers and SafeSet Reservoir kits due to a potential for leak.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for leak, which poses a risk of harm to patients, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 200 units of TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62. The product is the Transpac Disposable Straight Pressure Transducer (DSPT), which interfaces between a catheter and a pressure monitor. The recall also includes SafeSet Reservoir and blood sampling kits containing these transducers.
The recall was initiated because ICU Medical identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The SafeSet Reservoir system is used for periodic blood sampling on patients connected to the monitoring line.
The affected units were distributed nationwide. The source text does not specify the exact dates of distribution or the specific facilities affected beyond the nationwide distribution pattern. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electr
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 3227664
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 162 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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